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Comparative Efficacy Study of Titratable Versus Active Mandibular Advancement Splint in Sleep Apnea (SOMNYX)

Primary Purpose

Obstructive Sleep Apnea

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Somnyx ®
Narval ORM ® or SomnoDent ®
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, mandibular advancement splint, active mandibular advancement splint, oral appliance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age between 18 and 65 years
  • severe OSA confirmed by polysomnography (PSG) is: 30> AHI> 15 with severe daytime sleepiness - Epworth ≥ 10 or AHI> 30
  • patient in failure or refusal of CPAP treatment
  • agree to participate and sign the consent form research
  • speak and understand French without external assistance
  • be in good health (no neurological or psychiatric syndrome).
  • have a valid Social Security card (in France and Portugal only)

Exclusion Criteria:

  • contra-indicated dental/periodontal states for mandibular advancement splints, such as: 1) significant edentulism (less than 3 healthy teeth / quadrant), 2) generalized periodontitis or severe parodonthopathies, 3) severe disorders of the temporomandibular joint (TMJ), 4) less than 5 mm of maximal mandibular protrusion
  • dental restorations in progress or planned in the next 6 months
  • psychiatric and neuromuscular disorders
  • untreated cardiovascular diseases and history of stroke or myocardial infarction
  • severe or morbid obesity (body mass index> 35)

Sites / Locations

  • Université de MontréalRecruiting
  • Université MontpellierRecruiting
  • Groupe Hospitalier Pitie-SalpetriereRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Narval ORM ® or SomnoDent ®

Somnyx ®

Arm Description

Mandibular advancement splint (Narval ORM ® or SomnoDent ®)

Active mandibular advancement splint (Somnyx ®)

Outcomes

Primary Outcome Measures

Overall response rate
Overall response rate (ORR) = rate of complete response (TRc) + partial response rate (PRR) =% of patients with AHI <15 or ≥ 50% reduction in AHI and compliance ≥ 5 nights / week and 5 hours / night

Secondary Outcome Measures

Rate of Complete Response
Rate of Complete Response (TRc) =% Patients with AHI <15 and AHI ≥ 50% reduction and compliance ≥ 5 nights / week and 5 hours / night)
Partial response rate
Partial response rate =% of patients with reduction AHI ≥ 50% with AHI> 15 or AHI <15 with reduction <50% and adherence ≥ 5 nights / week and 5 hours / night) at 3 months of treatment.
Subjective compliance
Subjective compliance
Sleep quality
sleep efficiency, total sleep time
Desaturation
desaturation index, time spent below 90%
Subjective sleep
Pittsburgh questionnaire
Quality of life
Functional outcomes sleep questionnaire (FOSQ)
Fatigue
Chalder fatigue questionnaire
Subjective daytime sleepiness
Epworth sleepiness score
Side effects
side effects and interactions with the dental evaluations

Full Information

First Posted
April 5, 2014
Last Updated
May 10, 2018
Sponsor
Université de Montréal
Collaborators
Groupe Hospitalier Pitie-Salpetriere, University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02112435
Brief Title
Comparative Efficacy Study of Titratable Versus Active Mandibular Advancement Splint in Sleep Apnea
Acronym
SOMNYX
Official Title
Comparative Study of Efficacy of Titratable Mandibular Advancement Splint Versus Active Mandibular Advancement Splint to Treat Patients With Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal
Collaborators
Groupe Hospitalier Pitie-Salpetriere, University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Sleep apnea is a common disorder that occurs in 3-10 % of the adult population. This disorder disrupts the architecture and quality of sleep. Continuous positive airway pressure (CPAP) therapy is the standard treatment, but in some cases, it can not be used (patient refusal or intolerance). In these cases, treatment with mandibular advancement devices can bring an improvement in symptoms. Therefore, this study aims to compare the effectiveness of titratable versus active mandibular advancement splints in standard care environment. This will be based on the global response, which includes the apnea-hypopnea index and compliance in severe apnea patients who refused or where intolerant to CPAP. Following their severe apnea diagnosis and the assessment on the feasibility of placing a mandibular advancement device, follow-up visits will be scheduled after 3 months of treatment involving clinical monitoring by a physician and a dentist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, mandibular advancement splint, active mandibular advancement splint, oral appliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Narval ORM ® or SomnoDent ®
Arm Type
Active Comparator
Arm Description
Mandibular advancement splint (Narval ORM ® or SomnoDent ®)
Arm Title
Somnyx ®
Arm Type
Experimental
Arm Description
Active mandibular advancement splint (Somnyx ®)
Intervention Type
Device
Intervention Name(s)
Somnyx ®
Other Intervention Name(s)
Active mandibular advancement appliance, Oral appliance
Intervention Description
Active mandibular advancement splint
Intervention Type
Device
Intervention Name(s)
Narval ORM ® or SomnoDent ®
Other Intervention Name(s)
Mandibular advancement splint, Mandibular advancement appliance, Oral appliance, Mandibular repositioning appliance, Mandibular repositioning splint
Intervention Description
Mandibular advancement splint
Primary Outcome Measure Information:
Title
Overall response rate
Description
Overall response rate (ORR) = rate of complete response (TRc) + partial response rate (PRR) =% of patients with AHI <15 or ≥ 50% reduction in AHI and compliance ≥ 5 nights / week and 5 hours / night
Time Frame
following 3 months of treatment
Secondary Outcome Measure Information:
Title
Rate of Complete Response
Description
Rate of Complete Response (TRc) =% Patients with AHI <15 and AHI ≥ 50% reduction and compliance ≥ 5 nights / week and 5 hours / night)
Time Frame
following 3 months of treatment
Title
Partial response rate
Description
Partial response rate =% of patients with reduction AHI ≥ 50% with AHI> 15 or AHI <15 with reduction <50% and adherence ≥ 5 nights / week and 5 hours / night) at 3 months of treatment.
Time Frame
Following 3 months of treatment
Title
Subjective compliance
Description
Subjective compliance
Time Frame
Following 3 months of treatment
Title
Sleep quality
Description
sleep efficiency, total sleep time
Time Frame
Following 3 months of treatment
Title
Desaturation
Description
desaturation index, time spent below 90%
Time Frame
Following 3 months of treatment
Title
Subjective sleep
Description
Pittsburgh questionnaire
Time Frame
Following 3 months of treatment
Title
Quality of life
Description
Functional outcomes sleep questionnaire (FOSQ)
Time Frame
Following 3 months of treatment
Title
Fatigue
Description
Chalder fatigue questionnaire
Time Frame
Following 3 months of treatment
Title
Subjective daytime sleepiness
Description
Epworth sleepiness score
Time Frame
Following 3 months of treatment
Title
Side effects
Description
side effects and interactions with the dental evaluations
Time Frame
Following 3 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 18 and 65 years severe OSA confirmed by polysomnography (PSG) is: 30> AHI> 15 with severe daytime sleepiness - Epworth ≥ 10 or AHI> 30 patient in failure or refusal of CPAP treatment agree to participate and sign the consent form research speak and understand French without external assistance be in good health (no neurological or psychiatric syndrome). have a valid Social Security card (in France and Portugal only) Exclusion Criteria: contra-indicated dental/periodontal states for mandibular advancement splints, such as: 1) significant edentulism (less than 3 healthy teeth / quadrant), 2) generalized periodontitis or severe parodonthopathies, 3) severe disorders of the temporomandibular joint (TMJ), 4) less than 5 mm of maximal mandibular protrusion dental restorations in progress or planned in the next 6 months psychiatric and neuromuscular disorders untreated cardiovascular diseases and history of stroke or myocardial infarction severe or morbid obesity (body mass index> 35)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nelly Huynh, PhD
Email
nelly.huynh@umontreal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Gilles Lavigne, DMD, PhD
Email
gilles.lavigne@umontreal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelly Huynh, PhD
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3C3J7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nelly Huynh, PhD
Email
nelly.huynh@umontreal.ca
First Name & Middle Initial & Last Name & Degree
Gilles Lavigne, DMD, PhD
Email
gilles.lavigne@umontreal.ca
First Name & Middle Initial & Last Name & Degree
Nelly Huynh, PhD
First Name & Middle Initial & Last Name & Degree
Gilles Lavigne, DMD, PhD
Facility Name
Université Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves Dauvilliers, MD
Email
y-dauvilliers@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Yves Dauvilliers, MD
First Name & Middle Initial & Last Name & Degree
Olivier Gallet de Santerre, MD
First Name & Middle Initial & Last Name & Degree
Isabelle Bonafé, DMD
Facility Name
Groupe Hospitalier Pitie-Salpetriere
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carole Philippe, MD
Email
carole.philippe@psl.aphp.fr
First Name & Middle Initial & Last Name & Degree
Carole Philippe, MD
First Name & Middle Initial & Last Name & Degree
Valérie Attalie, MD
First Name & Middle Initial & Last Name & Degree
Stéfania Redolfi, MD
First Name & Middle Initial & Last Name & Degree
Isabelle Arnulf, MD
First Name & Middle Initial & Last Name & Degree
Jean-Marc Collet, MD
First Name & Middle Initial & Last Name & Degree
Patrick Goudot, PhD

12. IPD Sharing Statement

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Comparative Efficacy Study of Titratable Versus Active Mandibular Advancement Splint in Sleep Apnea

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